---
kind: "section"
citation: "21 C.F.R. § 821.20"
title: "21"
number: "821.20"
heading: "Devices subject to tracking."
url: "https://uscodex.org/cfr/21/821.20"
---

# §821.20. Devices subject to tracking.

- (a) A manufacturer of any class II or class III device that fits within one of the three criteria within [§ 821.1(a)](/cfr/21/821.1.md?p=a) must track that device in accordance with this part, if FDA issues a tracking order to that manufacturer.
- (b) When responding to premarket notification submissions and premarket approval applications, FDA will notify the sponsor by issuing an order that states that FDA believes the device meets the criteria of [section 519(e)(1)](/cfr/21/519.md?p=e-1) of the act and, by virtue of the order, the sponsor must track the device.

## Notes

### Amendments

[67 FR 5951, Feb. 8, 2002]

### Authority

Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374.

### Source

Source: 58 FR 43447, Aug. 16, 1993, unless otherwise noted.

### Amendments

[67 FR 5951, Feb. 8, 2002]